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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMyChoice® CDx
Generic NameCancer-related germline gene mutation detection system
ApplicantMyriad Genetic Laboratories, Inc.
320 Wankara Way
Salt Lake City, UT 84108
PMA NumberP190014
Supplement NumberS011
Date Received09/16/2025
Decision Date03/10/2026
Product Code PJG 
Advisory Committee Pathology
Clinical TrialsNCT02655016
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to update the MyChoice CDx assay labeling from a complementary diagnostic to a companion diagnostic to aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline or somatic BRCA1 and BRCA2 mutations and/or a positive genomic instability score, who are eligible or may become eligible for treatment with Zejula (niraparib).
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